WARNING LETTER
Max Chemical Inc.
MARCS-CMS 682037 —
June 20, 2024
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Ms. Magdalena Blanco
Recipient Title
President
Max Chemical Inc.
Calle La Brisa #7 Urb. Industrial Sabana Llana
San Juan
00924
Puerto Rico
Issuing Office:
Office of Pharmaceutical Quality Operations, Division II
1201 Main Street, Suite 7200
Dallas
,
TX
75202
United States
Case #: 682037
WARNING LETTER
Dear Ms. Blanco:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Max Chemical Inc., FEI 3002088200, at Calle La Brisa #7, Urb. Industrial Sabana Llana, San Juan, from March 11 to 15, 2024.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your April 3, 2024 response to our Form FDA 483 in detail. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.
During our inspection, our investigators observed specific violations including, but not limited to, the following.
1. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. (21 CFR 211.84(d)(1) and 211.84(d)(2)).
You failed to conduct an identity test on each shipment of each lot of components used in the production of your drug products, including the active ingredients (i.e., isopropyl and ethyl alcohol). Additionally, you relied on the certificates of analysis (COAs) from your suppliers and failed to establish the reliability of each of your suppliers’ COAs for component specifications and characteristics.
You also failed to determine whether each component conformed with all appropriate written specifications for purity, strength, and quality before using them. Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications before use in the manufacture of your drug products.
2. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess. (21 CFR 211.100(a)).
Your firm uses water as a component in your over-the-counter (OTC) drug products. Your water system is not adequately qualified and monitored to ensure the system is operating properly, and continuously producing water suitable for its intended use.
Water for pharmaceutical purposes must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. The lack of adequate validation provides no assurance the system performs as intended, and subsequent use of inadequately
(b)(4)
water in pharmaceutical manufacturing can adversely affect drug product quality and patient safety.
3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
Your firm failed to establish an adequate quality unit (QU) with responsibilities to ensure adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure:
•
Adequate finished product testing (21 CFR 211.165(a) and 211.165(b)).
•
Establishment of an adequate stability program (21 CFR 211.137(a)).
•
Adequate investigations of in-process testing failures (21 CFR 211.192).
•
Adequate training for employees engaged in the manufacture, processing, packing, or holding of drug products (21 CFR 211.25(a)).
Your firm’s quality systems are inadequate. See FDA’s guidance document
Quality Systems Approach to Pharmaceutical CGMP Regulations
for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.
Drug Production Ceased
We acknowledge your commitment to cease production of all drugs at this facility.
If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. Should you resume manufacturing drugs, based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.
Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.
Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Your written notification should refer to case #
682037
.
Please electronically submit your reply, on company letterhead, to Dayna I. Martinez, Compliance Officer, at ORAPHARM2_RESPONSES@fda.hhs.gov, and dayna.martinez@fda.hhs.gov.
If you have questions regarding the contents of this letter, you may contact Dayna I. Martinez via phone at (787) 729-8608 or email at dayna.martinez@fda.hhs.gov.
Sincerely,
Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
07/16/2024
Regulated Product(s)
Drugs