# FDA 483 - Ohm Laboratories, Inc. - August 12, 2009

Source: https://www.keypedia.com/records/483/ohm-laboratories-inc/014fcd7f-7694-42fd-a281-e28974dc7516

> FDA 483 for Ohm Laboratories, Inc. on August 12, 2009. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ohm Laboratories, Inc.
- Inspection Date: 2009-08-12
- Product Type: Drugs
- Office Name: New York District Office
- Summary: This FDA Form 483 documents numerous deficiencies observed during an inspection. The facility failed to include distributed drug product quantities in annual reports and did not submit an NDA-Field Alert Report within three working days for a distributed batch failing specifications.

Significant quality system and manufacturing issues were identified:
- Inadequate testing and record-keeping for drug product expiration dates.
- Absence of written production and process control procedures to assure drug product identity, strength, quality, and purity.
- Failure to document written production and process control procedures at the time of performance.
- Incomplete investigations into batch failures, not extending to other potentially affected batches or products.
- Unwritten and unfollowed responsibilities and procedures for the quality control unit.
- Insufficient qualified personnel for processing drug products.
- Lack of employee training in specific operations and GMP procedures.
- Deficient complaint records lacking investigation findings.
- Unspecified storage conditions in the written stability program for retained samples.
- Undescribed sampling and testing plans for drug products in written procedures.
- Unverified suitability of testing methods under actual use conditions.
- Deficiently written or followed instrument calibration procedures.
- Laboratory records lacking second-person review for accuracy and completeness.
- Failure to maintain backup files for computer data and lack of backup procedures to ensure data integrity.
- Inadequate controls over computer systems to restrict changes to authorized personnel.
- Incomplete records for testing and standardization of laboratory

## Related Officers

- [Stephen A. Campbell, Esq.](https://www.keypedia.com/people/stephen-a-campbell-esq/404ce650-6f62-4f66-9a90-1136fe8313f6)
- [other](https://www.keypedia.com/people/l-capron/c7a87f86-46cc-4422-a60a-9f566abbffad)

Company: https://www.keypedia.com/companies/ohm-laboratories-inc/8d38ef3a-8c55-47c4-89b4-f5fe41d851e8

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d