Findings
1Process validation
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 failed to validate the processes used to manufacture your drug products. In addition, you could not provide evidence that you have qualified all of your manufacturing equipment. In your response you state that you…
2Stability and storage
Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates. (21 CFR 211.166(a)). Your firm failed to establish an adequate stability program and determine appropriate expiration dates for the drug products that you manufacture. You assigned a three-year expiry period to many of your drug products but…
3Documentation and records
Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)). Your quality unit (QU) failed to provide adequate oversight of your CGMP records. For example, your batch record for Psoriasis Control Cream, lot (b)(4) , contained incomplete information. Additionally, your QU failed to follow your procedures for conducting annual product…
4Material and supplier control
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your firm manufactures over-the-counter (OTC) drug products such as skin protectant creams for eczema and diabetics. You failed to conduct adequate…
About this record
Extracted automatically from the document US FDA published on 2024-07-23. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
