# FDA 483 - Lee & Company - February 21, 2013

Source: https://www.keypedia.com/records/483/lee-company/7ba9a549-66d5-41ee-9c2f-ec22014c663f

> FDA 483 for Lee & Company on February 21, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lee & Company
- Inspection Date: 2013-02-21
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 details significant deficiencies at an unnamed facility manufacturing sterile drug products.

**Environmental Monitoring Deficiencies:**
*   Aseptic processing areas lack suitable procedures for monitoring ISO Class 5 environmental conditions.
*   No monitoring for viable and non-viable particles is conducted during aseptic filling; current practice involves static personnel, settling/contact plate, and non-viable particulate monitoring.
*   No dynamic studies exist to ensure filtered air flow patterns in the ISO Class 5 area.

**Sterilization Process Validation Issues:**
*   Procedures to prevent microbiological contamination lack validation of sterilization processes.
*   No qualification studies (e.g., [b] (4) studies) have been performed on [b] (4) used to sterilize vials, septums, equipment, and drug product, particularly with current loading patterns.
*   Sterilization of suspensions has not been validated.
*   The process for sterilizing empty vials and septums lacks established critical parameters (time, [b] (4) exposure) and loading patterns.

**Aseptic Technique and Media Fill Deficiencies:**
*   No written procedures establish operator aseptic technique (e.g., glove changes, sanitization frequency) during aseptic filling.
*   Media fill studies (SOP #7.1) are not representative of actual operations, using different vial sizes, colors, and lower fill volumes than routine production.

**Process Control and Stability

## Related Documents

- [WARNING_LETTER - 2013-02-21](https://www.keypedia.com/records/warning_letter/lee-company/f602ac13-123f-4914-afff-756caee68f59)

## Related Officers

- [Consumer Safety Officer (Investigator)](https://www.keypedia.com/people/torrance-slayton/4c696f8c-5d66-4465-aca4-e450e76eded9)
- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

Company: https://www.keypedia.com/companies/lee-company/3a038f03-aa6a-4988-a290-5748d3783bbf

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9