# FDA 483 - Wockhardt, Ltd. - December 15, 2015

Source: https://www.keypedia.com/records/483/wockhardt-ltd/6a3762ec-6bc4-4575-8d18-c27016b49959

> FDA 483 for Wockhardt, Ltd. on December 15, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wockhardt, Ltd.
- Inspection Date: 2015-12-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspection of a pharmaceutical manufacturing facility revealed multiple quality system and manufacturing deficiencies.

**Quality Unit Oversight and Documentation:**
*   Lack of Quality Unit oversight/approvals for document destruction, with shredded raw material labels, maintenance work orders, and hot work permits found awaiting incineration.
*   An uncontrolled personal diary containing experimental protocol and laboratory data, including calculations and molecular weights, was found in the Process Development Laboratory, which handles quality failure investigations and process testing.
*   Record entries were not always made contemporaneously or permanently, and corrections did not always preserve the original entry.

**Laboratory Control Issues:**
*   Aseptic media fill sterility testing for the Aseptic processing area used finished sterile API containers, but remaining containers were sampled but not tested for sterility, only retained for failure investigation.
*   Worst-case locations for microbial environmental swabs and contact plates in the sterile production area were not identified.
*   Three out of ten sterile gowns had unraveled stitching threads (1-3 cm) and one had shredded boot strap ties (>10 cm) in the sterile manufacturing block.
*   Lack of traceability for environmental isolates recovered from the production area, and microbial cultures were stored together in the same bag.
*   Operator interventions, including hand movements, interfered with unidirectional airflow during aseptic connections in a Laminar Air Flow unit, as observed in a smoke study simulation report.

**Computerized System Deficiencies:**
*   Prior to July

## Related Documents

- [WARNING_LETTER - 2015-12-15](https://www.keypedia.com/records/warning_letter/wockhardt-ltd/a7f6ceea-4425-47f5-adcd-1a564d67201c)

## Related Officers

- [ Assistant Country Director (USFDA India Office Drug Program)](https://www.keypedia.com/people/daniel-j-roberts/1e1836ac-8bca-4236-a267-33ee0456440c)

Company: https://www.keypedia.com/companies/wockhardt-ltd/47574b42-a0f5-4d97-b76b-bfe3ef6a1ec7

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