One of the more interesting and novel cancer therapies is the genetic engineering of the patients T-cells, where the cells are modified to target a specific protein expression on the cancer cell. However, this is a paradigm shift in manufacturing moving from a centralized manufacturing (what we see today at large pharmaceutical companies, or 503B Outsourcing Facilities) to a patient point-of-care or decentralized manufacturing model.  … more

503B Consent Decree

One of the tools FDA has to enforce laws and regulations are injunctions which may leed to a consent decree.  These tools are goverened by FDA Policy. Injunctions are managed through the Office of the Chief Counsel (OCC) per FDA policy. … more

Enviornmental Data Integrity

As identified in a recently posted FDA warning letter during the inspection, the FDA investigator requested the firm to provide all deviations from environmental monitoring limits.  The firm reported that they had no results outside limits for over a year prior to the inspection date…

However, during the inspection the FDA investigator found containers storing environmental and personnel monitoring microbiological samples, dated August 30 and 31, 2017.… more


Did you know that 503B Outsourcing Facilities are tracked under CDER Strategic Area 2 – Drug Quality and Compliance on the CDER Dashboard.

Section III identifies Inspections and Enforcement of Compounders.  This CDER Dashboard identifies by fiscal year the number of compounds that recalled products, the number of warning letters issued, the number of state referral letters, the number of injuctions/consent decrees, and the total number of regestered outsoursing facilities. … more

2018 503B Smoke Study Issues

In the first 6-months of 2018, fiftteen 503B Outsourcing Facilities were cited for smoke study issues.  Airflow is critical in maintaining sterile conditions, as described in the FDA Guide on Aseptic Processing

In an aseptic process, the drug product, container, and closure are first subjected to sterilization methods separately, as appropriate, and then brought together. … more


On May 29, 2018 FDA posted 9 warning letters to online retailers whose networks offered or introduced into interstate commerce, opioids that are misbranded and unapproved new drugs, in violation of sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act [21 U.S.C.… more

Dry Goods Autoclave

The Challenge

Recently a client contacted Performance Validation requesting assistance with the cycle validation for a dry goods autoclave, which had failed to achieve sterility.  A biological indicator included in the validation demonstrated growth on completion of the autoclave cycle.

The Solution

On review of the dry goods autoclave cycle, Performance Validation (PV), identified the autoclave used a gravity cycle. … more

What is a Facility – Updated

September 2016, I blogged about the draft FDA Guidance Facility Definition Under Section 503B of the FD&C act.  In May 2018, the draft guiance was approved and published in the Federal Register and is available here.

Industry Questions:

FDA has been asked whether an outsourcing facility can create a separate area within its facility for compounding according to patient specific prescriptions under section 503A, and not follow CGMP requirements in that area.… more

OTC Manufacturer Warning Letter

Recently a manufacturer of an OTC product was inspected by FDA (Nov 2017) and the resultant warning letter was posted on the FDA website May 2018.  This firm received 3 citations which are summarized below:

Observation 1 – the firm elected to manufacture the OTC product with raw material that had not been tested and released by the quality unit. … more

Blister Card Packaging Line Qualification

The Challenge

A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a new blister card packaging line for a new product launch, as well as facility and utility modifications to support the new packaging line.… more