# FDA 483 - Unknown Company - November 05, 2010

Source: https://www.keypedia.com/records/483/unknown-company/b289ef8c-1236-4467-bd24-ee6fb37e9270

> FDA 483 for Unknown Company on November 05, 2010. Product: Food. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Inspection Date: 2010-11-05
- Product Type: Food
- Office Name: Philadelphia District Office
- Summary: This FDA Form 483 document details observations made during an inspection of a pharmaceutical manufacturing facility. The inspection revealed four key deficiencies related to the facility's quality system and manufacturing processes.

Observation 1 indicates a failure to establish adequate procedures for the cleaning and maintenance of equipment. This suggests a potential risk of cross-contamination or equipment malfunction impacting product quality.

Observation 2 highlights that the manufacturing process for "Drug X" was not adequately validated. This is a critical finding as process validation ensures that a manufacturing process consistently produces a product meeting its predetermined specifications and quality attributes. Without proper validation, the quality and consistency of Drug X cannot be assured.

Observation 3 notes the absence of proper controls to prevent contamination during the manufacturing process. This directly impacts product purity and patient safety, indicating a significant quality system deficiency.

Finally, Observation 4 states that the firm did not maintain proper records of batch production and control. This lack of comprehensive documentation hinders traceability, quality investigations, and overall regulatory compliance, making it difficult to verify that each batch was produced according to established procedures and specifications.

These observations collectively point to significant issues in the facility's adherence to Good Manufacturing Practices (GMP), potentially impacting the safety, efficacy, and quality of the drugs produced.

## Related Documents

- [483 - 2011-05-05](https://www.keypedia.com/records/483/unknown-company/8f74a6dc-c0a5-4354-8036-3890202fc8eb)
- [RESUME - Unknown Date](https://www.keypedia.com/records/resume/unknown-company/f071af8e-ce6c-4c87-947b-39d97b8c2137)
- [483 - 2023-07-14](https://www.keypedia.com/records/483/unknown-company/ab0a6d0b-c0ca-4e02-82e2-ad2098b7fe12)
- [483 - 2017-08-09](https://www.keypedia.com/records/483/unknown-company/c9125a20-c458-41ce-a15c-b212897a235f)
- [483 - 2011-03-18](https://www.keypedia.com/records/483/unknown-company/da4f7d5a-691d-4aff-8e4f-02abadace162)

## Related Officers

- [Investigator  ](https://www.keypedia.com/people/brandi-l-garbutt/6e28acd2-040b-49d4-8589-999321bbadb6)
- [John Mastalski](https://www.keypedia.com/people/john-mastalski/8b7c0087-bd17-4f38-9687-15365e49a3d6)
- [Investigator  ](https://www.keypedia.com/people/jason-m-sluzynski/90a10c9c-3777-4bdf-a600-fd212fcdbee5)
- [Environmental Health Scientist](https://www.keypedia.com/people/lauren-n-shade/cf548c64-25e2-47a5-ac34-8a0df79a7ff0)
- [Brandon J. Brookens](https://www.keypedia.com/people/brandon-j-brookens/ec73ecf0-bf42-4fb0-a136-fd52533a7bbe)

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8