+-----------------+----+----------+---+---+---+-----+------+---------------+
| ### DEPARTMEN   |    |          |   | 1 |   |     |      |               |
| T OF HEALTH AND |    |          |   | \ |   |     |      |               |
|  HUMAN SERVICES |    |          |   | . |   |     |      |               |
|                 |    |          |   | D |   |     |      |               |
| FOOD AND DRUG   |    |          |   | I |   |     |      |               |
| ADMINISTRATION  |    |          |   | S |   |     |      |               |
|                 |    |          |   | T |   |     |      |               |
|                 |    |          |   | R |   |     |      |               |
|                 |    |          |   | I |   |     |      |               |
|                 |    |          |   | C |   |     |      |               |
|                 |    |          |   | T |   |     |      |               |
|                 |    |          |   | A |   |     |      |               |
|                 |    |          |   | D |   |     |      |               |
|                 |    |          |   | D |   |     |      |               |
|                 |    |          |   | R |   |     |      |               |
|                 |    |          |   | E |   |     |      |               |
|                 |    |          |   | S |   |     |      |               |
|                 |    |          |   | S |   |     |      |               |
|                 |    |          |   | A |   |     |      |               |
|                 |    |          |   | N |   |     |      |               |
|                 |    |          |   | D |   |     |      |               |
|                 |    |          |   | P |   |     |      |               |
|                 |    |          |   | H |   |     |      |               |
|                 |    |          |   | O |   |     |      |               |
|                 |    |          |   | N |   |     |      |               |
|                 |    |          |   | E |   |     |      |               |
|                 |    |          |   | N |   |     |      |               |
|                 |    |          |   | O |   |     |      |               |
|                 |    |          |   | . |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   | > |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
+-----------------+----+----------+---+---+---+-----+------+---------------+
| 2\. NAME AND    |    |          |   |   | 3 |     |      | 4\. SAMPLE    |
| TITLE OF        |    |          |   |   | \ |     |      | NUMBER        |
| INDIVIDUAL      |    |          |   |   | . |     |      |               |
|                 |    |          |   |   | D |     |      | >             |
| >               |    |          |   |   | A |     |      |               |
|                 |    |          |   |   | T |     |      |               |
|                 |    |          |   |   | E |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
+-----------------+----+----------+---+---+---+-----+------+---------------+
| 5\. FIRM NAME   |    |          | 6 |   |   |     |      |               |
|                 |    |          | \ |   |   |     |      |               |
| >               |    |          | . |   |   |     |      |               |
|                 |    |          | F |   |   |     |      |               |
|                 |    |          | I |   |   |     |      |               |
|                 |    |          | R |   |   |     |      |               |
|                 |    |          | M |   |   |     |      |               |
|                 |    |          | \ |   |   |     |      |               |
|                 |    |          | ' |   |   |     |      |               |
|                 |    |          | S |   |   |     |      |               |
|                 |    |          | D |   |   |     |      |               |
|                 |    |          | E |   |   |     |      |               |
|                 |    |          | A |   |   |     |      |               |
|                 |    |          | N |   |   |     |      |               |
|                 |    |          | U |   |   |     |      |               |
|                 |    |          | M |   |   |     |      |               |
|                 |    |          | B |   |   |     |      |               |
|                 |    |          | E |   |   |     |      |               |
|                 |    |          | R |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
+-----------------+----+----------+---+---+---+-----+------+---------------+
| 7\. NUMBER AND  |    |          | 8 |   |   |     |      |               |
| STREET          |    |          | \ |   |   |     |      |               |
|                 |    |          | . |   |   |     |      |               |
| >               |    |          | C |   |   |     |      |               |
|                 |    |          | I |   |   |     |      |               |
|                 |    |          | T |   |   |     |      |               |
|                 |    |          | Y |   |   |     |      |               |
|                 |    |          | A |   |   |     |      |               |
|                 |    |          | N |   |   |     |      |               |
|                 |    |          | D |   |   |     |      |               |
|                 |    |          | S |   |   |     |      |               |
|                 |    |          | T |   |   |     |      |               |
|                 |    |          | A |   |   |     |      |               |
|                 |    |          | T |   |   |     |      |               |
|                 |    |          | E |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
+-----------------+----+----------+---+---+---+-----+------+---------------+
| 9\. SAMPLE      |    |          |   |   |   |     |      |               |
| COLLECTED       |    |          |   |   |   |     |      |               |
| *(Describe      |    |          |   |   |   |     |      |               |
| fully. List     |    |          |   |   |   |     |      |               |
| lot, serial,    |    |          |   |   |   |     |      |               |
| model numbers   |    |          |   |   |   |     |      |               |
| and other       |    |          |   |   |   |     |      |               |
| positive        |    |          |   |   |   |     |      |               |
| i               |    |          |   |   |   |     |      |               |
| dentification)* |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
| The following   |    |          |   |   |   |     |      |               |
| samples were    |    |          |   |   |   |     |      |               |
| collected by    |    |          |   |   |   |     |      |               |
| the Food and    |    |          |   |   |   |     |      |               |
| Drug            |    |          |   |   |   |     |      |               |
| Administration  |    |          |   |   |   |     |      |               |
| and receipt is  |    |          |   |   |   |     |      |               |
| hereby          |    |          |   |   |   |     |      |               |
| acknowledged    |    |          |   |   |   |     |      |               |
| pursuant to     |    |          |   |   |   |     |      |               |
| Section 704(c)  |    |          |   |   |   |     |      |               |
| of the Federal  |    |          |   |   |   |     |      |               |
| Food, Drug, and |    |          |   |   |   |     |      |               |
| Cosmetic Act    |    |          |   |   |   |     |      |               |
| \[21 U.S.C.     |    |          |   |   |   |     |      |               |
| 374(c)\] and /  |    |          |   |   |   |     |      |               |
| or Section 532  |    |          |   |   |   |     |      |               |
| (b) of the      |    |          |   |   |   |     |      |               |
| Federal Food,   |    |          |   |   |   |     |      |               |
| Drug, and       |    |          |   |   |   |     |      |               |
| Cosmetic Act    |    |          |   |   |   |     |      |               |
| \[21 U.S.C.     |    |          |   |   |   |     |      |               |
| 360ii(b)\]      |    |          |   |   |   |     |      |               |
| and/or 21 Code  |    |          |   |   |   |     |      |               |
| of Federal      |    |          |   |   |   |     |      |               |
| Regulations     |    |          |   |   |   |     |      |               |
| (CFR) 1307.02.  |    |          |   |   |   |     |      |               |
| Excerpts of     |    |          |   |   |   |     |      |               |
| these are       |    |          |   |   |   |     |      |               |
| quoted on the   |    |          |   |   |   |     |      |               |
| reverse of this |    |          |   |   |   |     |      |               |
| form.           |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
| (**NOTE:** *If  |    |          |   |   |   |     |      |               |
| you bill FDA    |    |          |   |   |   |     |      |               |
| for the cost of |    |          |   |   |   |     |      |               |
| the Sample(s)   |    |          |   |   |   |     |      |               |
| listed below,   |    |          |   |   |   |     |      |               |
| please attach a |    |          |   |   |   |     |      |               |
| copy of this    |    |          |   |   |   |     |      |               |
| form to your    |    |          |   |   |   |     |      |               |
| bill.)*         |    |          |   |   |   |     |      |               |
|                 |    |          |   |   |   |     |      |               |
| >               |    |          |   |   |   |     |      |               |
+-----------------+----+----------+---+---+---+-----+------+---------------+
| 10\. SAMPLES    | 11 |          |   |   |   | 1   |      |               |
| WERE            | \. |          |   |   |   | 2\. |      |               |
|                 | AM |          |   |   |   | SIG |      |               |
| > PROVIDED AT   | OU |          |   |   |   | NAT |      |               |
| > NO CHARGE     | NT |          |   |   |   | URE |      |               |
| >               | RE |          |   |   |   | *(P |      |               |
| > PURCHASED     | CE |          |   |   |   | ers |      |               |
| >               | IV |          |   |   |   | ons |      |               |
| > BORROWED *(To | ED |          |   |   |   | rec |      |               |
| > be returned)* | F  |          |   |   |   | eiv |      |               |
|                 | OR |          |   |   |   | ing |      |               |
|                 | SA |          |   |   |   | p   |      |               |
|                 | MP |          |   |   |   | aym |      |               |
|                 | LE |          |   |   |   | ent |      |               |
|                 |    |          |   |   |   | for |      |               |
|                 | CA |          |   |   |   | sam |      |               |
|                 | SH |          |   |   |   | ple |      |               |
|                 | BI |          |   |   |   | or  |      |               |
|                 | LL |          |   |   |   | per |      |               |
|                 | ED |          |   |   |   | son |      |               |
|                 |    |          |   |   |   | pro |      |               |
|                 | V  |          |   |   |   | vid |      |               |
|                 | OU |          |   |   |   | ing |      |               |
|                 | CH |          |   |   |   | sam |      |               |
|                 | ER |          |   |   |   | ple |      |               |
|                 | C  |          |   |   |   | to  |      |               |
|                 | RE |          |   |   |   | FDA |      |               |
|                 | DI |          |   |   |   | at  |      |               |
|                 | T\ |          |   |   |   | no  |      |               |
|                 | CA |          |   |   |   | cha |      |               |
|                 | RD |          |   |   |   | rge |      |               |
|                 |    |          |   |   |   | .)* |      |               |
+-----------------+----+----------+---+---+---+-----+------+---------------+
| 13\.            |    | > 14\.   |   |   |   |     | 15\. |               |
| COLLECTOR\'S    |    | > COLL   |   |   |   |     | COLL |               |
| NAME *(Print or |    | ECTOR\'S |   |   |   |     | ECTO |               |
| Type)*          |    | > TITLE  |   |   |   |     | R\'S |               |
|                 |    | >        |   |   |   |     | S    |               |
| >               |    |  *(Print |   |   |   |     | IGNA |               |
|                 |    | > or     |   |   |   |     | TURE |               |
|                 |    | > Type)* |   |   |   |     |      |               |
|                 |    | >        |   |   |   |     |      |               |
|                 |    | >        |   |   |   |     |      |               |
+-----------------+----+----------+---+---+---+-----+------+---------------+
| **FORM FDA 484  |    |          |   |   |   |     |      | PAGE    OF    |
| (3/06)**        |    |          |   |   |   |     |      | PAGES         |
| PREVIOUS        |    |          |   |   |   |     |      |               |
| EDITION MAY BE  |    |          |   |   |   |     |      |               |
| USED **RECEIPT  |    |          |   |   |   |     |      |               |
| FOR SAMPLES     |    |          |   |   |   |     |      |               |
| PREVIOUS        |    |          |   |   |   |     |      |               |
| EDITION MAY BE  |    |          |   |   |   |     |      |               |
| USED** PREVIOUS |    |          |   |   |   |     |      |               |
| EDITION MAY BE  |    |          |   |   |   |     |      |               |
| USED            |    |          |   |   |   |     |      |               |
+-----------------+----+----------+---+---+---+-----+------+---------------+
|                 |    |          |   |   |   |     |      | PSC Media     |
|                 |    |          |   |   |   |     |      | Arts (301)    |
|                 |    |          |   |   |   |     |      | 443-1090 EF   |
+-----------------+----+----------+---+---+---+-----+------+---------------+

+---+---+-----------------------------------------------------------------+---+
|   |   | **Section 704 (c) of the Federal Food, Drug, and Cosmetic Act   |   |
|   |   | \[21 U.S.C. 374(c)\] is quoted below:**                         |   |
|   |   |                                                                 |   |
|   |   | \"If the officer or employee making any such inspection of a    |   |
|   |   | factory, warehouse, or other establishment has obtained any     |   |
|   |   | sample in\                                                      |   |
|   |   | the course of the inspection, upon completion of the inspection |   |
|   |   | and prior to leaving the premises he shall give to the owner,   |   |
|   |   | operator, or agent in charge a receipt describing the samples   |   |
|   |   | obtained.\"                                                     |   |
|   |   |                                                                 |   |
|   |   | **Section 532(b) of The Federal Food, Drug and Cosmetic Act     |   |
|   |   | \[21 U.S.C. 360 ii (b)\] is quoted in part below:**             |   |
|   |   |                                                                 |   |
|   |   | \"Section 532(b) In carrying out the purposes of subsection     |   |
|   |   | (a), the Secretary is authorized to-                            |   |
|   |   |                                                                 |   |
|   |   | \(1\) \*\*\*\*                                                  |   |
|   |   |                                                                 |   |
|   |   | \(2\) \*\*\*\*                                                  |   |
|   |   |                                                                 |   |
|   |   | \(3\) \*\*\*\*                                                  |   |
|   |   |                                                                 |   |
|   |   | \(4\) procure (by negotiation or otherwise) electronic products |   |
|   |   | for research and testing purposes, and sell or otherwise        |   |
|   |   | dispose of such products\"                                      |   |
|   |   |                                                                 |   |
|   |   | **21 Code of Federal Regulations 1307.02 is quoted below:**     |   |
|   |   |                                                                 |   |
|   |   | \"1307.02 Application of State law and other Federal law.       |   |
|   |   |                                                                 |   |
|   |   | Nothing in this chapter shall be construed as authorizing or    |   |
|   |   | permitting any person to do any act which such person is not    |   |
|   |   | authorized or permitted to do under other Federal laws or       |   |
|   |   | obligations under international treaties, conventions or        |   |
|   |   | protocols, or under the law of the State in which he/she        |   |
|   |   | desires to do such an act nor shall compliance with such be     |   |
|   |   | construed as compliance with other Federal or State laws unless |   |
|   |   | expressly provided in such other laws.\"                        |   |
|   |   |                                                                 |   |
|   |   | Therefore, in the event any samples of controlled drugs are     |   |
|   |   | collected by FDA representatives in the enforcement of the      |   |
|   |   | Federal Food, Drug, and Cosmetic Act, the FDA representative    |   |
|   |   | shall issue a receipt for such samples on FDA Form 484, RECEIPT |   |
|   |   | FOR SAMPLES, to the owner, operator, or agent in charge of the  |   |
|   |   | premises.                                                       |   |
|   |   |                                                                 |   |
|   |   | **Report of analysis will be furnished only where samples meet  |   |
|   |   | the requirements of Section 704(d) of the Federal Food, Drug,   |   |
|   |   | and Cosmetic Act \[21 U.S.C. 374(d)\] which is quoted below:**  |   |
|   |   |                                                                 |   |
|   |   | \"Whenever in the course of any such inspection of a factory or |   |
|   |   | other establishment where food is manufactured, processed, or   |   |
|   |   | packed, the officer or employee making the inspection obtains a |   |
|   |   | sample of any such food, and an analysis is made of such sample |   |
|   |   | for the purpose of ascertaining whether such food consists in   |   |
|   |   | whole or in part of any filthy, putrid, or decomposed           |   |
|   |   | substance, or is otherwise unfit for food, a copy of the        |   |
|   |   | results of such analysis shall be furnished promptly to the     |   |
|   |   | owner, operator, or agent in charge.\"                          |   |
+---+---+-----------------------------------------------------------------+---+
| F |   |                                                                 |   |
| O |   |                                                                 |   |
| R |   |                                                                 |   |
| M |   |                                                                 |   |
| F |   |                                                                 |   |
| D |   |                                                                 |   |
| A |   |                                                                 |   |
| 4 |   |                                                                 |   |
| 8 |   |                                                                 |   |
| 4 |   |                                                                 |   |
| ( |   |                                                                 |   |
| 3 |   |                                                                 |   |
| / |   |                                                                 |   |
| 0 |   |                                                                 |   |
| 6 |   |                                                                 |   |
| ) |   |                                                                 |   |
| B |   |                                                                 |   |
| A |   |                                                                 |   |
| C |   |                                                                 |   |
| K |   |                                                                 |   |
+---+---+-----------------------------------------------------------------+---+