# Thai Nakorn Patana Co., Ltd, – FDA 483, Aug 4, 2023

Source: https://www.keypedia.com/records/483/thai-nakorn-patana-co-ltd/97d9c4cf-d05d-4670-aeef-961114098240

> FDA 483 for Thai Nakorn Patana Co., Ltd, on August 04, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Thai Nakorn Patana Co., Ltd,
- Inspection Date: 2023-08-04
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: Thai Nakorn Patana Co., Ltd, a drug manufacturer in Mueang Nonthaburi, Thailand, was cited for significant deficiencies across its quality control laboratory, production processes, equipment management, and employee training. The inspection revealed failures in drug product testing, inadequate laboratory records for standards and calculations, undocumented deviations, and lack of proper equipment qualification and cleaning procedures. These issues indicate a systemic lack of adherence to Good Manufacturing Practices, potentially impacting the quality and safety of drug products distributed to the US market.

## Related Documents

- [WARNING_LETTER - 2023-08-04](https://www.keypedia.com/records/warning_letter/thai-nakorn-patana-co-ltd/b5ba4e62-9e43-4ed1-ab5c-bcf7f97a154a) — date: August 4, 2023

## Related Officers

- [James R. Birkenstamm](https://www.keypedia.com/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)

Company: https://www.keypedia.com/companies/thai-nakorn-patana-co-ltd/47bfd683-2d37-4211-9aa9-5643fc0460a1

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c