Answer:
The "Quality System" was deemed inadequate by the FDA due to violations of 21CFR211 regulations. In the Warning Letter, several sections were highlighted as being violated. Here are three sections of 21CFR211 that were violated, along with explanations:
1. Section 211.22(d): This section requires that all drug manufacturing processes be controlled to ensure the quality and purity of the final product. In the Warning Letter, it was noted that the company failed to establish and follow adequate procedures for the cleaning and maintenance of equipment. This violation suggests that the company did not have proper controls in place to prevent cross-contamination or ensure the integrity of the drugs produced.
2. Section 211.192: This section mandates that drug manufacturers have written procedures for the handling of complaints. The Warning Letter mentioned that the company did not adequately investigate customer complaints related to product quality and failed to document these investigations. This violation indicates that the company did not have an effective system in place to address and rectify quality issues raised by customers.
3. Section 211.100(a): This section states that drug products must be tested to ensure that they meet predetermined specifications. The Warning Letter pointed out that the company did not have adequate laboratory facilities for testing drug products. This violation suggests that the company lacked the necessary resources and infrastructure to carry out proper testing, compromising the assurance of product quality.
In summary, the "Quality System" was deemed inadequate by the FDA due to violations of 21CFR211 regulations. These violations included failure to establish proper procedures for equipment cleaning, inadequate handling of customer complaints, and a lack of adequate laboratory facilities for testing drug products. The evidence from the Warning Letter supports these conclusions.
Step-by-step explanation: