## Facts

- Bioclinical Systems, Inc. manufactured plated culture media used as in vitro diagnostic devices.
- The United States, acting through the FDA, alleged Bioclinical and two corporate principals violated the FDCA by failing to comply with medical-device good manufacturing practice (GMP) requirements.
- After the suit was filed, the court directed an FDA reinspection; an April 1987 report asserted 29 GMP violations.
- The alleged violations fell into two groups: (1) those tied to an asserted sterility assurance level (SAL) of 0.1% (no more than 0.1% contamination), and (2) those not tied to the SAL.
- The FDA’s 0.1% SAL expectation was based on internal compliance views and draft inspection guidance rather than a formally promulgated regulatory standard.
- Bioclinical disputed that a 0.1% SAL was a binding requirement and presented evidence that the relevant industry generally did not achieve that contamination rate.
- Several non-SAL issues were resolved or being corrected (e.g., sampling changes, updated operating procedures, making procedures available in work areas, ensuring adequate steam generation capacity).
- Bioclinical agreed to perform an additional validation study concerning the aseptic fill process.
- After an evidentiary hearing, the court found the government had not proven the remaining non-SAL violations.

## Issues

1. Whether FDA could treat a 0.1% sterility assurance level as an enforceable “current good manufacturing practice” for plated culture media under the FDCA.
2. Whether the government met its burden for a preliminary injunction under 21 U.S.C. § 332(a) based on the asserted SAL-related and non-SAL GMP violations.

## Decision

- The court denied the government’s motion for a preliminary injunction.
- The court found the government failed to prove the unresolved non-SAL GMP violations.
- The court rejected the 0.1% SAL as an enforceable GMP in this posture because it did not reflect “current” industry practice and was rooted in informal FDA materials rather than binding requirements.
- Without proof of enforceable violations, injunctive relief was not warranted.

## Legal Principles

- Under the FDCA, a device GMP must reflect “current good manufacturing practice,” which requires grounding in demonstrable, existing industry practice rather than an aspirational target.
- Informal agency materials (including draft inspection guidance and internal compliance expectations) may inform oversight but do not, standing alone, impose binding obligations equivalent to duly established standards.
- A preliminary injunction under 21 U.S.C. § 332(a) requires sufficient proof of ongoing or threatened statutory violations; failure to prove enforceable noncompliance defeats injunctive relief.

## Conclusion

The court declined to enjoin Bioclinical’s operations because the government did not prove the alleged non-SAL GMP deficiencies and could not enforce a 0.1% SAL as “current” GMP where the record showed the industry did not meet that level and the agency’s expectation was not established as a binding standard.


United States v. Bioclinical Sys., Inc., 666 F. Supp. 82 (D. Md. 1987)