# FDA 483 - John's Pharmacy Inc. - February 22, 2019

Source: https://www.keypedia.com/records/483/johns-pharmacy-inc/7837ccfc-a401-4386-93e7-55da6b8bd6ff

> FDA 483 for John's Pharmacy Inc. on February 22, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: John's Pharmacy Inc.
- Inspection Date: 2019-02-22
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: John's Pharmacy Inc. received an FDA Form 483 following an inspection conducted between February 12 and February 22, 2019. The inspection identified two significant observations related to the production of non-sterile drugs, indicating a need for improved adherence to quality standards.
The first observation cited the company for using non-pharmaceutical grade water in drug product formulations, including Omeprazole and Chlorpromazine. This water, produced by an in-house system, had never been tested for microbial quality, and no maintenance records were kept for the system, raising concerns about product purity and safety.
The second observation highlighted inadequate cleaning procedures for work surfaces and utensils used in the production of hazardous drugs. The FDA noted that equipment such as spatulas, mortars, pestles, and capsule filling machines were not adequately rinsed with qualified water or appropriate sanitizing agents after initial cleaning with soap and hot water. This deficiency, exemplified by the production of Zonisamide suspension and Triamcinolone Acetonide cream, poses a significant risk of cross-contamination between drug products.
John's Pharmacy Inc. is expected to address these observations by implementing comprehensive corrective actions to ensure all components meet pharmaceutical standards, and that cleaning and sanitation protocols effectively prevent contamination, thereby safeguarding drug product quality and patient safety.

## Related Documents

- [483 - 2019-02-22](https://www.keypedia.com/records/483/johns-pharmacy-inc/9b72166b-4134-428b-bf9e-a3476004db29)

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Constantin Y. Philopoulos](https://www.keypedia.com/people/constantin-y-philopoulos/536d53f5-7699-4b27-8b4b-10280cce9603)

Company: https://www.keypedia.com/companies/johns-pharmacy-inc/de7f2b42-46ba-4485-8270-bd4da8263798

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03