# FDA 483 - TECHNICHEM CORP - March 18, 2020

Source: https://www.keypedia.com/records/483/technichem-corp/c1bf7d36-08c2-4c19-859f-11be0ac328b2

> FDA 483 for TECHNICHEM CORP on March 18, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TECHNICHEM CORP
- Inspection Date: 2020-03-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: TECHNICHEM CORP in Anaheim, CA, was inspected and received a Form 483 with eight observations indicating significant deficiencies in their drug manufacturing processes. Key issues include inadequate environmental controls, lack of component testing and vendor qualification, unsupported product stability data, and incomplete batch records. The firm also failed to establish and follow procedures for quality control decisions, complaint handling, annual product reviews, and process validation.

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## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

Company: https://www.keypedia.com/companies/technichem-corp/88af00e1-e12e-4ecc-afc9-186501702155

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6