# FDA 483 - The Micro Connection Enterprises, Inc. DBA Personal Care Performance Group - May 06, 2022

Source: https://www.globalkeysolutions.net/records/483/the-micro-connection-enterprises-inc-dba-personal-care-performance-group/8236606c-849e-4704-afc1-26bb6451b7cd

> FDA 483 for The Micro Connection Enterprises, Inc. DBA Personal Care Performance Group on May 06, 2022. Product: cosmetics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Micro Connection Enterprises, Inc. DBA Personal Care Performance Group
- Inspection Date: 2022-05-06
- Product Type: cosmetics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The Micro Connection Enterprises dba Personal Care Performance received a Form 483 citing significant deficiencies across its quality system and laboratory operations. Observations included severe data integrity issues with electronic records, inadequate quality control unit oversight and complaint investigations, and critical failures in water system validation and monitoring. The firm also failed to conduct proper annual product quality reviews and lacked scientifically sound laboratory controls for API testing and growth promotion.

## Related Documents

- [483 - 2019-10-30](https://www.globalkeysolutions.net/records/483/the-micro-connection-enterprises-inc-dba-personal-care-performance-group/8bdbc87d-ba2e-456a-b8a1-a4bff4ffd8dd)

## Related Officers

- [Carolina D. Vasquez](https://www.globalkeysolutions.net/people/carolina-d-vasquez/ffa9d542-e660-4575-831e-f11a2de4b978)
- [investigator](https://www.globalkeysolutions.net/people/heidy-c-perales/fdf71c74-8cb7-41b5-9070-6b8eb11cb404)

Company: https://www.globalkeysolutions.net/companies/the-micro-connection-enterprises-inc-dba-personal-care-performance-group/abc9965f-4d85-4da8-8a83-039b120065e1

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6