# FDA 483 - Vitalab Pharmacy, Inc. DBA Vasco Rx Specialty Pharmacy - August 02, 2019

Source: https://www.keypedia.com/records/483/vitalab-pharmacy-inc-dba-vasco-rx-specialty-pharmacy/ffa73b3a-eb57-47fc-8713-8b25accd44a3

> FDA 483 for Vitalab Pharmacy, Inc. DBA Vasco Rx Specialty Pharmacy on August 02, 2019. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Vitalab Pharmacy, Inc. DBA Vasco Rx Specialty Pharmacy
- Inspection Date: 2019-08-02
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: This FDA Form 483 document details observations made during an inspection of a pharmaceutical manufacturing facility. The inspection revealed three key deficiencies related to the production of sterile drug products.

Observation 1 indicates that the firm failed to establish an adequate system for monitoring environmental conditions in the aseptic processing area. This suggests a potential risk to the sterility of the drug products due to insufficient control over the manufacturing environment.

Observation 2 notes that the firm did not adequately validate the sterilization process for equipment used in the production of sterile drug products. This is a critical finding as proper sterilization validation is essential to ensure that equipment is free of microbial contamination, directly impacting product sterility and patient safety.

Observation 3 highlights that the firm did not conduct thorough investigations into discrepancies and failures in batch production records. This indicates a weakness in the firm's quality system, specifically in its ability to identify, investigate, and resolve deviations, which could lead to recurring issues and compromise product quality.

Collectively, these observations point to significant issues within the firm's quality control and manufacturing processes for sterile drug products, potentially impacting product sterility, efficacy, and patient safety. The firm is required to address these observations and implement corrective actions.

## Related Documents

- [483 - 2018-04-04](https://www.keypedia.com/records/483/vitalab-pharmacy-inc-dba-vasco-rx-specialty-pharmacy/68fae2f5-a62a-4fa3-be71-f2f9be3e3c9f)
- [483 - 2019-08-02](https://www.keypedia.com/records/483/vitalab-pharmacy-inc-dba-vasco-rx-specialty-pharmacy/ac532169-eb14-4eb4-a84c-4ca7000a07aa)
- [145 - 2020-02-06](https://www.keypedia.com/records/145/vitalab-pharmacy-inc-dba-vasco-rx-specialty-pharmacy/9a5c3822-eb56-4e66-9d13-9a0368e3824b)
- [STATE_REFERRAL_LETTER - 2019-07-22](https://www.keypedia.com/records/state_referral_letter/vitalab-pharmacy-inc-dba-vasco-rx-specialty-pharmacy/77b9c0ce-3f67-42a1-b11d-32baa1c8a6e0)

## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

Company: https://www.keypedia.com/companies/vitalab-pharmacy-inc-dba-vasco-rx-specialty-pharmacy/f432902e-cf2e-40cb-a5c0-9ecaf53efeef

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face