FDA 483 - FirstCham Co., Ltd. - October 27, 2023

This FDA Form 483 details observations from an inspection, citing multiple deficiencies in a drug manufacturing operation.

**Observation 1** notes that drug products failing to meet established specifications and quality control criteria are not rejected. Specifically, two batches of a product (Batch numbers [redacted] and [redacted]) were distributed to the US despite receiving Out-of-Specification (OOS) results for assay, exceeding the specified percentage.

**Observation 2** indicates that responsibilities and procedures for the quality control unit are not in writing and fully followed. This includes the absence of a Standard Operating Procedure (SOP) for good documentation practices, as evidenced by correction tape covering original data on growth promotion testing forms.

**Observation 3** highlights a lack of validation procedures. The firm lacks an SOP for validation and has not validated its manufacturing process (compounding and packaging), cleaning methods for equipment, microbiological methods for total microbial count, or chemical analytical methods, including assay.

**Observation 4** states that GMP training is not conducted on a continuing basis with sufficient frequency to ensure employee familiarity with CGMP requirements.

**Observation 5** points out the absence of a written testing program to assess drug product stability characteristics.

**Observation 6** identifies that specific identification tests are not conducted on components accepted based on supplier reports of analysis.

**Observation 8** notes that the suitability of all testing methods is not verified under actual conditions of use. Specifically, the